Clinical Evaluation of the Zynex Monitoring System, Model CM-1600

This is a prospective, single-arm, non-randomized, non-controlled single-center study for the evaluation of the Zynex CM-1600 in 20 healthy adults undergoing a manual blood loss of up to 500mL followed by an infusion of 1 liter of normal saline.

Study Overview

• Status: Completed
• Conditions: Fluid Loss
• Intervention / Treatment: Device: CM-1600

• Study Type: Interventional
• Enrollment (Actual): 20
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Colorado
    • Louisville, Colorado, United States, 80027
      • Clinimark

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

• Participant must have the ability to understand the parameters of participation and provide written informed consent
• Male or female of any race
• Participant is adult 18 or older
• Participant must be willing and able to comply with study procedures and duration
• In the Principal Investigator's medical judgment, the participant is suitable for a blood draw of up to 500mL
• Participant must weigh at least 110 pounds

Exclusion Criteria:

• Any upper extremity amputation
• Females who are pregnant, who are trying to get pregnant, or have a urine test positive for pregnancy on the day of the study
• Participant has a heart condition that may interfere with the Zynex CM-1600 (e.g., pacemakers, defibrillator, irregular heartbeat, dextrocardia, etc.)
• Participant has been diagnosed with chronic fatigue syndrome (also known as chronic fatigue, immune dysfunction syndrome, or myalgic encephalomyelitis)
• Participant requires equipment and/or devices that may interfere with the Zynex CM-1600 (e.g., life-sustaining equipment, other monitoring devices, insulin pumps, or other implanted devices)
• Participant is taking coumadin (warfarin), heparin, or other prescription blood thinners for 7 or more days prior to blood draw
• Participant donated blood within 8 weeks prior to the study blood draw
• Participant has high or low blood pressure on the day of blood draw (high blood pressure is defined as systolic > 180 mmHg or diastolic > 100 mmHg; low blood pressure is defined as systolic < 100 mmHg or diastolic < 60 mmHg)
• Participant has symptoms of an active infection or a temperature ≥ 100 °F
• Female with hemoglobin levels of less than 12.1g/dL or male with hemoglobin levels of less than 13.8g/dL

• Participants with self-reported heart or cardiovascular conditions such as:

  • History of cardiovascular surgery
  • History of chest pain (angina)
  • Heart rhythms other than a normal sinus rhythm or respiratory sinus arrhythmia
  • History heart attack/myocardial infarction
  • Peripheral arterial disease
  • Carotid artery disease
  • Unexplained shortness of breath
  • Congestive heart failure (CHF)
  • History of stroke/transient ischemic attack
  • Myocardial ischemia
  • Cardiomyopathy
  • Dextrocardia

• Participants with clotting disorders such as:

  • Hemophilia
  • History of blood clots
  • History of bleeding problems
  • Bruises easily

• Self-reported health conditions as identified in the Health Assessment Form including:

  • Diabetes
  • Uncontrolled thyroid disease
  • Kidney disease / chronic renal impairment
  • History of seizures (except childhood febrile seizures)
  • Epilepsy
  • History of unexplained syncope
  • Recent history of frequent migraine headache within the last 2 months
  • Recent head injury within the last 2 months
  • History of cancer, with or without chemotherapy within the last 2 months
• Other known health conditions deemed unsuitable for participation by the PI when considered upon disclosure on health assessment form

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Blood Loss and Saline Infusion	Device: CM-1600; Healthy subjects undergoing a manual blood loss of up to 500mL followed by an infusion of 1 liter of normal saline will be connected to the CM-1600 device.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
CM-1600 Ability to Detect Minor Blood Loss	The objective of this study is to determine if manual blood loss of up to 500mL of blood can be identified using the non-invasive Zynex CM-1600. This will be measured by determining the percent change in Relative Index (RI) before and after the Blood Draw. The RI is an investigational value which utilizes proprietary algorithms to combine the changes of multiple measured parameters (utilizing a weighted summation of percent change values) which are indicative of relative changes in fluid volume in adult patients into a single value. The RI is a unitless value with no set minimum or maximum, where 100 is a patient's baseline. Based on the nature of the RI itself, a direct interpretation of a positive or negative outcome cannot be derived from the absolute value, instead it could be used to monitor trending of a patient's parameters relative to their baseline.	Duration of Recovery Period following blood draw (10 minutes)
CM-1600 Ability to Detect Saline Reinfusion	The objective of this study is to determine if a saline reinfusion of 1000mL of normal saline can be identified using the non-invasive Zynex CM-1600. This will be measured by determining the percent change in Relative Index (RI) before and after the Saline Reinfusion. The RI is an investigational value which utilizes proprietary algorithms to combine the changes of multiple measured parameters (utilizing a weighted summation of percent change values) which are indicative of relative changes in fluid volume in adult patients into a single value. The RI is a unitless value with no set minimum or maximum, where 100 is a patient's baseline. Based on the nature of the RI itself, a direct interpretation of a positive or negative outcome cannot be derived from the absolute value, instead it could be used to monitor trending of a patient's parameters relative to their baseline.	Recovery period following saline reinfusion (10 minutes)

Collaborators and Investigators

• Sponsor: Zynex Monitoring Solutions

Publications and helpful links

Helpful Links

• Related Info

Study record dates

Study Major Dates

• Study Start (Actual): February 13, 2023
• Primary Completion (Actual): February 22, 2023
• Study Completion (Actual): February 22, 2023

Study Registration Dates

• First Submitted: February 13, 2023
• First Submitted That Met QC Criteria: February 13, 2023
• First Posted (Actual): February 23, 2023

Study Record Updates

• Last Update Posted (Actual): July 16, 2024
• Last Update Submitted That Met QC Criteria: June 20, 2024
• Last Verified: June 1, 2024

More Information

Terms related to this study

• Other Study ID Numbers: PR 2022-516

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No